MUSIDORE PED Study

Pain Management Clinical Trial

— MUSIDORE  

Official title:

Pain Management Via Music Therapy During Cleaning Cares in Pediatric Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03916835
• Other study ID #: UF 7654
• Status: Completed
• Phase: N/A
• Start date: May 28, 2019
• Est. completion date: May 20, 2020

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to measure the efficacy of music during a painful procedure in pediatric intensive care unit.

Music therapy has real effects on the pain level already proven in adults units. Our objective is to apply this technic to children. The investigators will evaluate this technic during cleaning care which is daily procedure for each stable patient and wich may be painful in this population.

Description:

Pediatric intensive care units may be anxious places. A lot of painful and stressful procedures are done every day. A simple care such as a simple cleaning care may become painful or uncomfortable.

Usually those situation require the use of painkillers. For several years, new approaches are used in order to decrease the pain level without medication such as hypnosis or music therapy. Music therapy proved efficacy to reduce pain in different procedures and is currently used in adult intensive care units in order to decrease anxiety and pain.

One specific program, "Music Care" is based on a "U sequence" which use tempo and rhythm variations following the U scheme, to relax patients.

This program will be evaluated in our department and the investigators will study the effects on the pain level during a cleaning care .

The patients will be evaluated during two consecutive cleaning cares. One with and the other without music therapy. The investigators will compare the variation of the FLACC scores (before and during cleaning care ) to show a difference between both methods. The order (with or without) will be randomized. The patient will be his one control.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 15 Years

Eligibility

Inclusion Criteria:

• Infants between 6 months and 15 years old

• Vigil child

• Admitted to the department of Pediatric Critical Ill Unit at University Hospital in Montpellier (France)

• Signed both parental consent.

• Signed both parental authorization for videotape recording

• Parents or person with legal authority who speaks and understands french

Exclusion Criteria:

• Deaf child

• Refusal of the child to participate in the study

Related Conditions & MeSH terms

• Music Therapy
• Pain Management

Intervention

Device:
• Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.
Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy. Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind. Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized.

Locations

Country	Name	City	State
France	Hopital Arnaud de Villeneuve- CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The FLACC (Face Legs Activity Cry Consolability) scale's score	The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Day 1 : 10 minutes before the care
Primary	The FLACC (Face Legs Activity Cry Consolability) scale's score	The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Day 1: During the care
Primary	The FLACC (Face Legs Activity Cry Consolability) scale's score	The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Day 2: 10 minutes before the care
Primary	The FLACC (Face Legs Activity Cry Consolability) scale's score	The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	Day 2: During the care
Secondary	Cardiac frequency	Values found on a device	Day 1 : 10 minutes before the care
Secondary	Cardiac frequency	Values found on a device	Day 1 : During the care
Secondary	Cardiac frequency	Values found on a device	Day 2 : 10 minutes before the care
Secondary	Cardiac frequency	Values found on a device	Day 2 : During the care
Secondary	breathing frequency	Values found on a device	Day 1: 10 minutes before the care
Secondary	breathing frequency	Values found on a device	Day 1: During the care
Secondary	breathing frequency	Values found on a device	Day 2: 10 minutes before the care
Secondary	breathing frequency	Values found on a device	Day 2: During the care
Secondary	Mean arterial pressure	Values found on a device	Day 1: 10 minutes before the care
Secondary	Mean arterial pressure	Values found on a device	Day 1: During the care
Secondary	Mean arterial pressure	Values found on a device	Day 2: 10 minutes before the care
Secondary	Mean arterial pressure	Values found on a device	Day 2: During the care
Secondary	Duration care	Time management during cleaning cares	Day 1
Secondary	Duration care	Time management during cleaning cares	Day 2